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Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors
Atema,Vera van Leeuwen,Marieke Oldenburg,Hester S. A. Retel,Valesca van Beurden,Marc Hunter,Myra S. Aaronson,Neil K.
Atema,Vera
van Leeuwen,Marieke
Oldenburg,Hester S. A.
Retel,Valesca
van Beurden,Marc
Hunter,Myra S.
Aaronson,Neil K.
Abstract
Background: Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms. Methods/design: In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) postrandomization. Discussion: Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause.
Description
Date
2016-11-25
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Publisher
Research Projects
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Keywords
Breast cancer, Menopause, Hot flushes, Cognitive behavioral therapy, Internet-based, Self-management, eHealth, Randomized controlled trial, Cost-effectiveness, QUALITY-OF-LIFE, PLACEBO-CONTROLLED TRIAL, SF-36 HEALTH SURVEY, HOT FLUSHES, NIGHT SWEATS, REPLACEMENT THERAPY, SALPINGO-OOPHORECTOMY, DOUBLE-BLIND, SELF-HELP, WOMEN, SDG 3 - Good Health and Well-being
Citation
Atema, V, van Leeuwen, M, Oldenburg, H S A, Retel, V, van Beurden, M, Hunter, M S & Aaronson, N K 2016, 'Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors', BMC Cancer, vol. 16, 920. https://doi.org/10.1186/s12885-016-2946-1